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October 03, 2006 October 3rd to October 9th October 3rd: FDA Approves Medafor's Arista(TM) AH Absorbable Surgical Hemostat for U.S. Operating Rooms Medafor, Inc. announced today that its Arista(TM) AH Absorbable Hemostat has received FDA approval to be marketed within the United States. Arista AH has been distributed internationally since 2002 and has compiled a remarkable record of surgical success around the world. In the U.S., this easy-to-use, efficacious and safe hemostat is indicated for most types of surgery including cardiac, orthopedic, spinal and general surgical applications. Arista AH consists of Medafor's patented Microporous Polysaccharide Hemospheres (MPH®), a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. Arista AH facilitates the formation of a highly resilient, natural clot within just a few minutes regardless of the patient's coagulation status. Arista AH is the only new generation surgical hemostat that is instantly ready to use, requiring no mixing, no addition of patient blood or other components and no special handling or storage conditions. Pre-clinical evaluations, clinical studies and surgical use have shown the hemostatic capabilities of Arista AH to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for rapid absorption. Arista AH is fully absorbable with studies substantiating no trace of the material at the wound site within 24 to 48 hours of application, and because Arista AH degrades rapidly, it does not promote infection. Medafor, Inc., is a privately held Minnesota Corporation based in Minneapolis. October 5th: New Non-Invasive Applications for LED Light Therapy From Photo Therapeutics A versatile, new, multi-treatment LED (Light Emitting Diode) device from the pioneer of photodynamic therapy is changing how dermatology and plastic surgery patients are treated. Today's consumer wants more effective, less aggressive skin treatments for acne, rosacea, psoriasis, and a variety of other skin disorders as well as to repair aging and sun-damaged skin, and the highly versatile Omnilux is the answer. With three easily inter-changeable treatment heads, each with a selective wave length and light intensity, Omnilux' pure, narrow-band light activates a series of cellular responses in the mitochondria, the powerhouse of the cells, to naturally correct a wide array of skin disorders. Omnilux light therapy selectively stimulates various cellular functions: Revive stimulates the fibroblasts to produce more collagen and elastin giving skin more firmness and an improved texture; Omnilux Blue and Plus help regulate other skin functions, such as sebum (oil) production, inflammation and wound healing. More than 2,200 physicians worldwide are now using Omnilux Light Therapy in their practice, and their grateful patients are spreading the word. A safe modality for all skin colors, Omnilux not only repairs signs of aging, but also reduces post-surgery healing time by accelerating wound healing after more invasive procedures. Light therapy actually reduces erythema (redness), pain and swelling after chemical peels, dermabrasion, IPL and laser surgery and even after plastic surgeries such as blepharoplasty (eyelid surgery) and mammoplasty (breast surgery). Omnilux is completely pain-free, and generally requires a series of 6 to 8 treatments performed on clean skin over a 4 to 8 week period. The Omnilux light trio is an FDA-approved medical device, whose scientific heritage spans nearly 20 years. It is FDA approved for both safety and efficacy, and is supported by more than forty-five independent peer review studies, plus Omnilux treatments are compatible with other existing skin rejuvenation procedures such as Botox(TM), dermal fillers and thread lifts. Protected by more than 35 worldwide patent applications by the parent company, Photo Therapeutics, in Staffordshire, England, is considered the world leader in the science and research of Light Therapy. Omnilux Light Therapy treatments are available only through physicians and leading medical esthetic spas across the country. October 9th: Possis Medical Inc. Receives FDA Approval for Fetch(TM) Aspiration Catheter Possis Medical, Inc. (NASDAQ--NMS:POSS) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Fetch(TM) Aspiration Catheter. Utilizing catheter technology from the company's premier AngioJet® Rheolytic(TM) Thrombectomy System, the Fetch Aspiration Catheter offers physicians another alternative for the aspiration of small, fresh blood clots (thrombus) and other embolic debris from arteries. "Our goal is to offer physicians a full range of solutions for thrombus removal," said Robert Dutcher, chairman, president and CEO of Possis Medical. "Our AngioJet Thrombectomy System continues to grow as the market leader and gold standard for thrombectomy in peripheral, coronary and dialysis access interventions. Although manual aspiration catheters such as the Fetch catheter offer much less thrombus removal capability than the AngioJet Thrombectomy System, the addition of the Fetch Aspiration Catheter provides physicians with a quick and simple means to aspirate small amounts of fresh thrombus and embolic debris from small coronary arteries. "As the recognized leader in thrombus management, the addition of the Fetch Aspiration Catheter to our product line further enhances our position as an increasingly valuable partner to our 1,800 current customers who deal with thrombus," said Dutcher. According to Possis, the rapid exchange Fetch Aspiration Catheter uses an industry-standard syringe as its aspiration source. To provide the flexibility and handling that interventional procedures require, Fetch features an advanced braided shaft design used in other AngioJet thrombectomy catheters marketed by Possis. Additionally, the Fetch catheter is 0.014" guidewire and 6F guide catheter compatible. "Our proprietary convex tip design, combined with a small outer diameter and hydrophilic coating, minimizes vessel trauma and enhances deliverability. In-house testing showed that the Fetch catheter often outperforms other currently available aspiration devices in the key areas of trackability, contrast injection and aspiration rate. Fetch is a valuable addition to our expanding range of thrombus management and broader endovascular therapies," said Dutcher. Possis will market the Fetch Aspiration Catheter in the Unites States through the company's sales organization and internationally through an established network of Possis distributors. Anticipated revenue from Fetch catheter sales is reflected in the company's current guidance.
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